Vocational Training is an obligation in all specialties under the EU Health laws. This means that if a specialty is listed on the specialist register of a country, it is not only an exam which is required to work, but specific Vocational Training (VT). The EU obliges government to guarantee for patients that anyone working with the National Health Services should have VT.

Tied to this however must come a strong proposal that those who hold an MD alone, unless they qualified for the specialist register by the one-off grandfather clause, will not be allowed to practice. There are varying opinions on this. Some continue to assert that an MD degree should be an exit degree allowing one to practice; others consider it a basic ‘entrance’ degree which enables one to specialize in a particular field. Wth family medicine considered as a specialty at EU level and in the rest of the Western World, one has to question the legitimacy of practicing in the community without having completed specialist training (unless one qualified for a grandfather clause). If one obliges VT, then it will only be an entrance degree. One cannot not argue for other areas, but certainly, if we feel that VT is not only a guarantee, but it is worth something extra, then it is about patient rights, and as patient advocates, doctors must uphold this principle. It is a question of who is competent to work in the community as happens in other specialties. Although I may take the risk and remove an appendix, I would be in a very tight position if I were to defend myself in front of a medical council. I cannot see how someone can escape negligence and malpractice. Although there are instances where countries require GPs to work in areas of specialization, they would not be on the specialist register and there is a limit to what they can do. This means in effect that what they do is still regulated and the MD qualification would not be enough.

We must also consider that we are in the EU and that by giving registration to private family doctors, the government has in effect acknowledged that private FPs are now part of the NHS and ties itself with this directive.

Actually this directive binds countries even if family medicine is not considered a specialty. In Italy the government has taken to control primary care and employs a fixed quantity of doctors calculated on a thousand patients per doctor. VT is imposed, even though family medicine is still not on their specialist register. It is not merely about the register. It is about quality, and about asserting that before we send doctors working in the community, they have been exposed to the local situations and know how to deal with non-manifest agendas, which often are not seen in the hospital setting. One must be astute to detect domestic violence, and offer treatment to substance abuse and help the family to cope. Being versant with all the available services does not come that quick. If one is to be registered with a doctor, this doctor must cover a comprehensive care – from children to elderly and from palliative care to offering some minor procedure and investigations. All WONCA core competencies must be satisfied.

The key therefore, for a successful implementation of patient registration, is to make sure that the doctors are adequately qualified and uniformly distributed according to population density. This does not mean that someone who works in a government health department may not form part of a group or network, so long as he or she is on the specialist register. But it does mean that doctors should not be allowed to be following one specialty and be allowed to sit in a pharmacy seeing patients which they will abandon as soon as they pass their membership exams. Having Vocation Training is about patients’ rights. It is not about the right to chose to do VT or not. The government has now taken in and acknowledged the important role private doctors do for our NHS. With this come moral responsibilities to our patients.

It will also mean making a jump in quality assurance, pharmacovigilance, infectious disease surveillance etc. If we have doctors who do not have patients registered with them practicing in parallel, this may mean that these quality improvements will not occur. For example, patients who hold a Schedule V card often have drugs which have been prescribed by specialists within the secondary setting. They go to primary care for prescriptions. Although hospital specialists and primary care specialists may be held to a different standard of care for certain drugs, the primary care physician writing the prescription still has responsibility of pharmacovigilance and other monitoring and examination duties. When patients do not have one doctor, one finds that several may be writing out a prescription within a period of time. This may lead to decisions by different people to change a dose or to a related drug without proper communication and records. Patient registration will put more responsibility on the doctor to ascertain any necessary changes and to monitor their conditions; it is often the case that a patient comes for a prescription and refuses examination or testing because he claims to have had them recently at another doctor or the health centre. If one is taking responsibility for prescribing drugs, it would make medico-legal and ethical sense to monitor the patient as well.

Certainly conditions must be satisfied for GPs to have patients registered with them. The first is a minimum number of hours in their practice – usually 20 hours have been suggested. Secondly they should be networked to cover for out-of-hours and emergency calls and when one is on leave. Networking works just as good in other countries as group practices, which have not proved popular. This has been the case in Italy from where colleagues have explained their system. It will also prevent business-like services, bringing in doctors from other countries who are not on the specialist register of their own country or have not done vocational training to practice here at the expense of quality and due care.

But the fact we are seeing a silver lining is indeed a step forward for patients and doctors alike. The effort invested by many over the years and especially in recent months is paying off.

The recent Englaro case has again given rise to the controversy of keeping a person alive in a persistent vegetative state (PVS) by nutrition and hydration through a nasogastric tube. The last controversial case which made a similar outcry was that of Terry Sciavo in the United States. The question to consider is whether nutrition and hydration, especially after several years in a PVS constitutes an ordinary measure to keep a person alive or an extraordinary and/or heroic one.

The difference between Ordinary / Extraordinary treatment originates from Roman Catholic Medical Ethics and was introduced by Pope Pius XII in the 50s, as a guidelines to Catholics in the face of new extraordinary means to keep people alive which were becoming more and more common. In fact before being able to keep people alive on a life support system, one was considered dead when one’s heart stops beating. (This still applies for medico-legal purposes, say, when one attempts cardiac resuscitation – if the attempt fails one cannot be accused of having caused death). A Harvard neurologist introduced the Brain Death Criteria, to determine whether a person is still scientifically alive and therefore allowing removal of the body from advanced life support.

The first controversial case, ironically, was to put a girl off life support when she was in fact not yet brain dead1. Mary Quinlan was a 21 year old on life support. She had been involved in an accident. She also was Roman Catholic as were her parents. The parents thought that keeping her alive on such a system was something they could not bear. They wanted her to die in dignity. Their Parish Priest defended their case. The doctors however would not agree as she was not brain dead. The case went to court, which made historical ground when it was decided that the criteria of a social institution (in this case the Catholic religion) could over-ride scientific thought. She was subsequently removed from life support and allowed to die even though she was not brain dead.

At this juncture it is important to note that the definition of the Church, subsequently put through scholarly rigour2 takes note of two particular (and important) points. First, what is to be defined as ordinary or extraordinary has nothing to do with the state-of-the-art medicine used in such cases. Blood transfusion was then considered as quite an extraordinary form of treatment. Today it is very common place. Yet we still note the controversy over Jehovah Witnesses, which to them is an extraordinary measure. What is ordinary for one person, such as having CPR, may be considered extraordinary for another. In this regard, having an Advance Directive (or living will) can be very helpful.

This brings up the second point – the relatives. The burden of the relatives is considered very important in determining whether treatment is ordinary or extraordinary. Therefore if the relatives have to go through extraordinary measures, such as selling a house, or extreme psychological distress, as in the Quinlan Case, then the treatment is considered extraordinary.

It is here that cases become controversial, although in reality they should remain confidential. The fact that respect for confidentiality seems not to take place here implies that we are still in an evolutionary phase of understanding these cases, and there is still to be found a balance between what is important to the patient/relatives, and what is important to society.

Roman Catholic moralists have however traditionally argued, as in the Quinlan case, that moral obligation demands only the use of ‘ordinary’ means:

Extraordinary means of preserving life are all medicine, treatments, and operations, which cannot be obtained or used without excessive expense, pain or other inconvenience for the patient or for others, or which, if used, would not offer a reasonable hope of benefit to the patient.2

Whilst it is important to note that the statement, accepted as ‘dogma’ nowadays, as it follows directly from the declaration of Pope Pius XII, includes ‘others’. The Quinlan case showed how true to the word this is. When it comes to nutrition and hydration however there is still controversy among ethicists.

Many ethicists consider nutrition and hydration to be so basic as to always constitute an ‘ordinary’ measure. Just as much ethicists however still believe that this is not the case. These arguments arise on whether to start a person in a PVS on hydration and nutrition. Definitely a person in such a state cannot be considered to experience hunger in the psychological state. Any nutrition and hydration does not give any satiety or satisfaction. It is simply to keep the physiological status of the body. The Englaro case showed, as opposed to the Sciavo case, how much life can be being held on a thread with nutrition. Jonsen, Siegler and Winslade, following Catholic moral teaching, propose that since controversy exists, both positions are ethically permissible and there is legal ground for both3. Certainly, Jonsen is a renowned Catholic theologian in the U.S.

What is unfortunate about these cases is that all forms of confidentiality are lost; people become overly emotional and judgemental about the relatives, and the application of the moral rule of what constitutes extraordinary is lost to public scrutiny and opinion. Some countries may decide to legislate to make things easier. This of course will remove one’s right to having advance directives about one’s own care, which seemed to be the issue in this case as well[NCBA1] .

There will hopefully come a time when we can have a structure which protects both patients and family, keeping the dignity of the situation. This would have to include some form of scrutiny to avoid abuse. Certainly if we decide that both options (giving or withholding nutrition and hydration) are both morally permissible, such policing would not be necessary. For many, living in a PVS for over seventeen years is extraordinary in itself. Other than contact with the person who feeds them two or three times a day, these people usually remain alone all day.

There is a growing literature and evidence on people in PVS. Some drugs have been shown to improve their condition and even bring them back to a relatively normal life. Classifications are continuously developed with further understanding. Indeed many do recover within the first six months. After that the chances are very slim and deteriorate with time. There are exceptional cases and it may be the case that one will be able to identify these with further knowledge on these cases obtained by the use of imaging techniques. There is certainly not enough evidence at the moment and one has to respect that there is an evolutionary phase for both definitions (ordinary and extraordinary treatments). Does nutrition in cases of PVS become extraordinary after a few years? Should we allow the person to die in dignity or leave them in this abyss, if abyss it is?

Conversely PVS has been around since the early seventies, when it was described by a neurosurgeon from Scotland. It is a side-effect of modern medicine, and we are still in the evolutionary phase of understanding even the classification, let alone the state itself. In the meantime should we be ‘prudent’ and give physiological feeding to these people and keep them in this abyss for seventeen years; or should we build an evidence-based literature which guides us as to when, early in the process, feeding would be considered extraordinary? For the family it is always difficult, but as with life support systems, there will be those who, as in the Quinlan case, would see any advancement as a technology which interferes with the natural dying process. There will be others who, even after the relative is brain dead, will object to the removal, thinking that since their heart can be kept beating, then there is still the possibility of a miracle. We have moved forward with life support systems, and chances are that we will move forward in PVS.

The first part of this article has tackled the issue of separating the main moral argument at hand from other moral pragmatic issues. It was seen that when negotiating moral problems it is sometimes clear what the main argument is – such as, ‘Should we have InVitro Fertilization?’ or ‘Should we sell organs?. On the other hand, other moral arguments, called pragmatic, may not be the main argument but can still have weight on the final acceptance of the moral issue at hand.

Pragmatic arguments are those which may be resolved in time, with advancing technology. On the other hand, ethical arguments are other moral issues which may not be resolved but which in themselves present another moral argument for discussion. In the previous argument, autostimulation to produce a sample of sperm for IVF was considered an ethical issue. It is not pragmatic as this cannot be resolved in time. Yet it is legitimately another moral argument. It should be made clear that this was not the main argument being discussed, if what was being deliberated was IVF. It may merit a separate discussion and within that context be put into the category (or box) labelled ‘moral’. But that would then be another argument.

Another example is freezing of embryos. This again is considered immoral by many. However it cannot be the main argument against the use of IVF, as it may be bypassed. Conversely it is another ethical issue and may merit discussion on its own, being then put in the category of ‘moral’. It is not a pragmatic issue however as it is not a technology which can be improved, other than its omission.

Sometimes we can be unclear as to whether an argument is simply pragmatic or ethical and therefore we have the convenient category labelled ‘unknown’. We can come to it later without sidelining the arguments at hand. For example, one argument often brought into the case for IVF is that couples should not be encouraged to go through extreme sacrifices like selling a house; for others, having a baby may be more important than owning a large, nice house.

Principles Matrix

Another ethics matrix convenient for use is that developed by Ben Mepham which considers a principles approach. Mepham uses three principles: well-being, autonomy and Fairness. It is basically an attempt to move away from the four-principled approach developed by Beauchamp and Childress which have been discussed in this column in previous articles, ie autonomy, beneficence, non-maleficence, and justice. He applies this matrix, an example of which is given here, in various parts of his book, dealing with many areas of bioethics.

Respect for:

Well-being

Autonomy

Fairness

Farmers

Satisfactory income

Managerial freedom

Fair trade laws and practices

Consumers

Food Safety

Informed choice

Affordable food

The Biota

Conservation

Biodiversity

Sustainability

Genetically Modified Crop

Flourishment

Adaptability

Intrinsic value

The above matrix deals with genetically modified crops. In reality fairness is a principle used in justice. Justice has fairness and equality as two principles usually defined within it. However one may separate justice into ‘equality’, and ‘fairness’ or put beneficence and non-maleficence in one category for convenience, according to the topic being discussed. One should keep in mind that the four principles proposed by Beauchamp and Childress do not resolve moral problems. They simply allow a framework for discussion and allow one to formulate a path for arriving to a conclusion. This conclusion however is usually based on separate issues than the four principles alone, such as respect for life, which can be used therefore to arrive at quite opposite conclusions. They nevertheless are the main principles discussed in moral discourse.

Autonomy

Beneficence

Non-maleficence

Justice

Patient

Can/cannot make a choice

Treatment

Side effects

What is in his/her best interest?

Relatives

Who is to act as proxy?

Information

Giving (bad) news

Any right to knowledge

Medical team

Explaining/taking medical choices

Is treatment futile?

Balance benefits with side effects

Cost/benefit ratio

Community

Does it have a say?

Can others benefit?

Slippery slope arguments

Justice to the community

In the case of Terre Schiavo - the American brain-injured woman who died nearly four years ago, after doctors removed the feeding tube that had sustained her for more than a decade - one may apply the four principles to all parties concerned: the patient, the husband & parents, the religious community at large, and the medical team making the decision. We usually balance between principles and specify them to the situation; but arriving at a moral conclusion is usually an a priori affair. One uses the matrix simply to put one’s arguments in a clear, understandable, and common ethical language. Not all boxes need be ‘filled’.

by Pierre Mallia MD MPhil PhD MRCP FRCGPAssociate Professor of Family Medicine and Patients’ RightsDepartment of Family Medicine, Medical SchoolUniversity of Malta

The PUME matrix helps us define ‘what are we discussing’. In a moral debate we often bring in many arguments, some of which have to do directly, and others indirectly with the main moral issue at hand. Moreover the moral issue may lead to other ethical choices and to areas or issues of which we are unsure. In order to clarify one’s thinking, in teaching and in moral debate, it is useful to distinguish therefore the main moral argument at hand, for example, sale of organs, from the pragmatic moral issues which arise - which indeed can have weight on the outcome. Then there are other ethical choices to be made – are there exceptions when we can tolerate the sale of an organ, for example if it is put as a condition in one’s will – is it ethical? There are areas which we are unsure about – unsure whether they form part of the main moral argument or are more pragmatic such as the use of masturbation as an argument against Invitro Fertilization. PUME stands for Pragmatic, Moral, Unsure and EthicalI.

The four main areas therefore are:

The central MORAL question being discussed.

PRAGMATIC moral issues related to the central moral question.

Areas in which we are UNSURE between the above.

Other ETHICAL outcomes or choices related to this issue.

PRAGMATIC

UNSURE

MORAL

ETHICAL

Figure 1: PUME Matrix

We see that areas 2, 3, and 4 can all have an influence on the central moral question. This means that although we can find nothing inherently wrong with the central issue, the other three areas can have enough weight to make it overall prohibitive, as we shall see. Conversely, the central issue may be inherently wrong, for example the use of animals in experiments, but under certain circumstances, and because of the benefits, we allow it. Clarifying areas 2 – 4 is important as the reasoning may change in time. Thus we tolerate pollution to have cars, but if cars exceed a limit, the pollution may be too much, or indeed we may have created other problems, such as congestion. We then revisit the central argument.

Having a matrix with these for areas, allows for better clarification in thinking, and especially in discussion. The matrix has indeed been used in group discussions both for teaching and public debates and can be used by a facilitator to focus the argument. He may, for instance, say, ‘yes, indeed, that is an important point. It is perhaps a pragmatic moral argument, which although important, is not the main issue we are discussing; it is more of an outcome of the issue, which if resolved, will still leave us having to answer what we are debating here. Let us put it under Pragmatic Moral Issues.’

The PUME matrix is a mnemonic to remember four areas of a moral debate. It is useful insofar as it helps one distinguish between the true moral arguments and those which can be ‘resolved’. This helps one distinguish in turn what are the true areas of conflict, where there is a difference in values, and areas of potential dispute, which if resolved, can help move one forward. One has to keep in mind that we may resolve a hundred disputes without resolving the main conflict, given that the conflict has to do more with a difference in values. To illustrate this by an external example, one can resolve many disputes between the Jewish and Palestinian states, and yet the main conflict between them remains. On the other hand, we may not really have a strong objection to the moral issue per se, but what matter more are the other moral issues which are raised. These I term the ‘pragmatic issues’. This is clearly illustrated by the cases for Invitro Fertilization and that of Organ Transplantation described below.

The reason for putting them in a matrix is two-fold. A matrix makes it easier to picture a problem. One can separate the arguments and put them into the respective box. This can even be done in one’s mind, since it is simple. Conversely, the columns on the left hand side are the main moral arguments, whilst the columns on the right are outcomes and choice with which we still have to deal. On the other hand, if we look at the matrix as rows, the upper row deals with moral issues external to the problem at hand, whilst the lower row is more inherent to the problem. Even if some are not the main issue at hand (the ethical choices), they are a direct result of the moral issue.

On the other hand the most important column for discussion is the left. We have to immediately divide the moral issues into the pragmatic ones and the real one being discussed. In the example of organ transplantation, the real issue is the morality of sale of organs; abuse of sale, or exploitation are pragmatic moral issues, which albeit can have an overall weight and become themselves the moral issues to decide the fate of the moral issue being discussed, are not in and of themselves the central moral issue – sale of organs. Conversely, with IVF, the fact that IVF can result in children with defects is indeed a moral issue, but a pragmatic one. If we resolve it, we are still faced with the moral issue of whether IVF is a morally good thing. People may then focus on the real discussion.

The matrix may or may not be useful to some, however it does have the advantage of clearly defining what we are talking about and at least agreeing on what is at stake and what is the true moral issue and what is not.

________________________________________________________________

I The PUME matrix was devised over several years of public debate and reflective teaching in bioethics with students of the University of Malta, and not least after the training imparted in Malta in adult learning, by the RCGP. I had been using the argument of separating the main argument at hand, from those other moral issues that arise from the main one, in order to create less confusion and to focus on the argument at hand.

by Pierre Mallia MD MPhil PhD MRCP FRCGPAssociate Professor of Family Medicine and Patients’ RightsDepartment of Family Medicine, Medical SchoolUniversity of Malta

If medicine had no philosophy, no ethos, then there is nothing to stop us from making profit the main principle and from considering the motive factor as morally correct. This would be relativism at its best. Even if paradigms may be the rule of the day, it does not mean they are always correct (and many, including myself, do not believe in Big Bang, a term which after all was coined by its great opponent Fred Hoyle. Many are blind however and continue to work notwithstanding many unanswered questions). What results is that we try to build an ethics which suits our needs, as scientists would try to work around experiments which prove rather than disprove a theory.

This is perhaps the challenge of modern medicine today. We must not lose sight of what MacIntyre1 calls the ‘practice’, which as a ‘tradition’ defines the goals and goods internal to the practice, even if the practice itself can have the benefits of ‘external’ goods, such as profits and prestige. The fact that we have to a certain extent omitted this has meant that defining and teaching of ethics within the medical community has been lost to external forces such as philosophy and sociology – all inputting, defining and dictating what doctors should or should not be doing. When the same people come on the hospital bed they will realise that they have been shouting in vain as they may indeed realise that the science of medicine is not, after all, the enemy. Then maybe, these much important fields will help medicine by becoming facilitative rather than didactive – that is, by helping the profession maintain its identity by their important contributions. Doctors will indeed appreciate the value of philosophy because they feel the need to define the philosophy of medicine. Medicine can only work within the cultural, social, and psychological spheres and does not concern itself, even if the rest of science does, with solely the scientific and biological. Perhaps that is why it continues to procure the title of an ‘art’ as well as a science. Yet it has to maintain a sense of what it stands for; even if assisted suicide may become acceptable to society, does this mean that doctors should do it?

Thus whereas Popper may have been wrong by strongly opposing what he called ‘historicism’, that is, the notion that historical instances made us into what we are today (one cannot argue that the second world war did not teach us lessons. One can forgive Popper for his ideas as he was an exiled Jew during the war, but what the ‘historicist’ philosophers such as Hegel really meant was that both good and bad work towards forming humanity, and not, that we are not free to choose our paths. He seemed to interpret Hegel as too deterministic on humanity and that thus the attempt at the extermination of the Jews was an inevitable process); Kuhn, on the other hand, with his notion of paradigms, puts us in dangerous grounds of having to define our ethos by the socio-psycho-cultural ‘paradigm’ of the day. This sets us back to having medicine defined by the regimes and thoughts of the day – as indeed was reflected in the Nuremberg trials.

If you have to be within a tradition to understand it and formulate your ethos with the changing times, then perhaps, Popper, with his limitations, gives us a better working formula, for at the end of the day medicine does move forward in research by ‘challenges’ to current thought, and when it comes to moral values and the goals of medicine, as MacIntyre said in his more analytical book Whose Justice, Which Rationality?2, a tradition is upheld when it withstands the challenges of the times. This is why he upholds Aristotelian and Thomistic morality over the geneologists like Neitchze and Foucault who resent conservatism. Yet with its limits, conservative values have withstood challenges in time and indeed it is because of what was built on conservative values that the so-called post-modernist thought can build its nest. Yet at the same time conservatism has responded to changing times as well. If Christian values have withstood many tests in time, then one cannot blame medicine for upholding those values before it ventures too deep into research such as the New Genetics – for that would be the philosophy of this ‘tradition’. To do this properly one has to give due importance to teaching young doctors the philosophy of their practice and tradition, which otherwise would simply be subject to relativist thoughts. One cannot then speak of a unifying tradition any longer.

by Pierre Mallia MD MPhil PhD MRCP FRCGPAssociate Professor of Family Medicine and Patients’ RightsDepartment of Family Medicine, Medical SchoolUniversity of Malta

The first thing we need to ask is whether philosophy of science matters at all for medicine; and indeed what do we mean by philosophy of science anyway? Perhaps the best way is to answer the question whether medicine, as a science, depends on tradition, and secondly, if there is a tradition, what are the goals of this tradition. Prima facie most doctors would agree that there is a tradition of medicine, which is to heal patients and to do good. Yet this tradition is being challenged when some doctors fell it their duty of assist in ending the life of a suffering individual. When one asks whether this is or should be the goal of medicine, one is making an inquiry about the philosophy of one’s practice. Even if it is not the aim, the ethos, of medicine, it may still be within the grasp of the general aim of scientific method. To illustrate this better, we can use reproductive technology or stem cell research as an example. Scientific advances in this area by no means held back the medical profession from using them; at least the former. Yet some may still challenge them on moral grounds outside medicine and then ask whether it should be within the scope of medical practice to host these technologies which some (or many) may question on moral grounds.

There are two principal movements in the philosophy of science, which can be applied to medicine, which have made their voice heard even in circles not inherent to the field. These are those of Karl Popper and Thomas Kuhn. Both did not concern themselves with medicine, but with philosophy of science per se. Popper is portrayed as the more objectivist and traditional, putting science on a level of challenges. We uphold a theory until it is challenged by a better one. The good scientist thus allows his theory as a working tool but is open to challenges and indeed may challenge it himself. Kuhn, on the other hand can be thought of more as coming from the American Pragmatic school and is considered more liberal and indeed relativist, saying that science moves forward by the practice or though of the day, which he called paradigms. These paradigms create small revolutions in themselves and scientists work around them. It is therefore more authoritarian and based on historical research as well. This historicism is a learning experience, if you may, on which one builds. Yet when a paradigm changes, all the material of the previous thoughts are put aside. Kuhn was a physicist and limited his discussion to this field. A clear example was theoretical physics which at the time was passing through a revolution of thought because of general relativity, quantum physics. Cosmology, with the ‘Big Bang’ created this new paradigm of thought, for example, and cosmologists work around this theory even though some still challenge the Big Bang concept.

Do we do the same in medicine? In many ways, we do. We speak of current thoughts in medical practice and historical development do take their toll. If one asks whether medicine is liberal or indeed relativist, there are indeed those who would go to all means in order to cure patients, or indeed to gain external advantages, given the necessity of industry to push forward medical research and development. Thus some would little question the embryo once this is for the gain of benefits obtained by stem cell research. Yet medicine has it long tradition and we take joy in speaking about the Hippocratic Oath and such. When it comes therefore to the teaching of bio- and medical ethics, one often appeals to tradition; but this tradition does change with the times. The principle of respecting autonomy has, for example, challenged paternalism – the notion that the doctor knows all and the patient must obey.

Does this matter at all? Indeed if medicine is to maintain its repute as doing good, it does. Doctors who are paternalistic are not only challenged but may face trouble. Whereas in the past it was relatively fine to take organs from dead bodies for research and study purposes; today medicine has fallen in line with obtaining consent and indeed has pioneer the concept of ‘informed’ consent – something which the business world, for example, including those giving out medical insurance, must still master. Moreover medicine has become socialized Today people are more and more aware of their cholesterol, weight, exercise. Far from what certain authors say, that medicine has manipulated the world, this is the result of society. The very fact that many other social factors come into play in medicine – politics, insurances, pharmaceutical industry etc, implies that there are more that doctors and paramedics involved in health care. This breeds the question – should these not all have the same ethics? Should they be obliged to follow the rules of medicine?

If we can speak of a philosophy of medicine, then we can answer in the affirmative. This would oblige insurance, politicians, and even brands promoting a certain butter to follow the same rules – that of respecting the principles which we as doctors uphold – respecting autonomy, beneficence, nonmaleficence and justice. Whilst the latter would apply mostly to politicians, we would not tolerate advertising which works upon scare mongering techniques – if you do not choose this butter you may be at a disadvantage; or manipulation – such as facial creams ‘approved’ by dermatological foundations sponsored by the same company producing the cream. As conflicts of interest apply to doctors, they should apply to anyone who is in any way making a profit on patients.

If medicine had no philosophy, no ethos, then there is nothing to stop us from making profit the main principle and motive factor as morally correct. This would be relativism at its best. Even if paradigms may be the rule of the day, it does not mean they are always correct (and many, including myself, do not believe in Big Bang, a term which after all was coined by its great opponent Fred Hoyle. Many are blind however and continue to work notwithstanding many unanswered questions). What results is that we try to build an ethics which suits our needs, as scientist would try to work around experiments which prove rather than disprove a theory.

This is perhaps the challenge of modern medicine today. We must not lose sight of what MacIntyre calls the ‘practice’, which as a ‘tradition’ defines the goals and goods internal to the practice, even if the practice itself can have the benefits of goods ‘external’, such as profits and prestige. The fact that we have to a certain extent omitted this has meant that defining and teaching of ethics within the medical community has been lost to external forces such as theology, philosophy and sociology – all inputting, defining, dictating what doctors should or should not be doing. When the same people come on the hospital bed they will realise that they have been shouting in vain as they may indeed realise that the science of medicine is not, after all, the enemy. Then maybe, these much important fields will help medicine by becoming facilitative rather than didactive – that is, by helping the profession maintain its identity by their important contributions. Doctors will indeed appreciate the value of philosophy because they feel the need to define the philosophy of medicine. Medicine can only work within the cultural, social, and psychological spheres and does not concern itself, even if the rest of science does, with solely the scientific and biological. Perhaps that is why it continues to procure the title of an ‘art’ as well as a science. Yet it has to maintain a sense of what it stands for; even if assisted suicide may become acceptable to society, does this mean that doctors should do it?

Thus whereas Popper may have been wrong by strongly being opposed to what he called ‘historicism’, that is, the notion that historical instances made us into what we are today (one cannot argue that the second world war did not teach us lessons. One can forgive Popper for his ideas as he was an exiled Jew during the war, but he took too much to heart the ‘historicist’ philosophers such as Hegel, who really meant that both good and bad work towards forming humanity, and not, that we are not free to choose our paths. He seemed to interpret Hegel as too deterministic on humanity and that thus the attempt at the extermination of the Jews was an inevitable process); Kuhn, on the other hand, with his notion of paradigms, puts us in dangerous grounds of having to define our ethos by the socio-psycho-cultural ‘paradigm’ of the day. This sets us back to having medicine defined by the regimes and thoughts of the day – as indeed was reflected in the Nuremberg trials.

If you have to be within a tradition to understand it and formulate your ethos with the changing times, then perhaps, Popper, with his limitations, gives us a better working formula, for at the end of the day medicine does move forward in research by ‘challenges’ to current thought, and when it comes to moral values and the goals of medicine, as MacIntyre said in his more analytical book Whose Justice, Which morality?, a tradition is upheld when is withstands the challenges of the times. This is why he upholds Aristotelian and Thomistic morality over the geneologists like Neitchze and Foucault who resent conservatism. Yet with its limits, conservative values have withstood challenges in time and indeed it is because of what was built on conservative values that the so-called post-modernist thought can build its nest. Yet at the same time conservatism has responded to changing times as well. If Christian values have withstood many tests in time, then one cannot blame medicine for upholding those values before it ventures too deep into research such as the New Genetics – for that would be the philosophy of this ‘tradition’. To do this properly one has to give due importance to teaching young doctors the philosophy of their practice and tradition, which otherwise would simply be subject to relativist thoughts. One cannot then speak of a unifying tradition any longer.

by Pierre Mallia MD MPhil PhD MRCP FRCGPAssociate Professor of Family Medicine and Patients’ RightsDepartment of Family Medicine, Medical SchoolUniversity of Malta

Psychiatrists in the UK have recently lamented the need for a code of ethics for psychiatry.1-3 There is a clear difference between a code of ethics and a code of practice (such as the non-statutory one of the UK Mental Health Act of 1983) or indeed a code of conduct. Sarkar and Adshead (2003) argue for the need to protect the patient in a world which is becoming more and more contractarian and utilitarian. Indeed the public often views psychiatrists as having to protect it from psychiatric patients and because of this the latter are put at a higher risk for detention. Codes of conduct and practice are therefore not sufficient for psychiatrists1 as patients put trust in these professionals to “protect their interests when they are not well enough to protect themselves”.

There are a number of issues in which psychiatric ethics differs from mainstream clinical ethics, mostly having to do with the vulnerability of this group of patients and indeed their mental incapacity. Indeed Sarkar and Adshead argue that the relative incapacity of patients to make decisions for themselves puts them in an especially vulnerable situation because they depend on others. In the UK this translates often into a ‘complete loss of autonomy’ and even patients’ competent refusal may, under British law, be over-ridden, even though psychiatric patients, even in-patients, may be perfectly capable of taking some decisions and participating in one’s choice for treatment.2 Even in forensic psychiatry it has been noted that for public interests, the interests of the patient may not be fully observed and that a code of ethics which trumps justice over other principles needs to be addressed in these specific areas.3

A common point raised is the vulnerability of patients, which may lead to sexual abuse – an exploitation of the vulnerability. This has been raised frequently in the United States, but certainly, according to General Medical Council data and information from voluntary groups, Sarkar and Adshead point out that the problem is not uncommon in the UK. In point of fact it seems to be entirely legal in the UK to have sexual relationships with a psychiatric patient ‘so long as the patient is not detained’.3

Thirdly, the Royal College of Psychiatrists4 points out the need for psychiatrists to ensure that the risk of detaining patients more than necessary is reduced. Psychiatry risks harming people by treating them unjustly and in fact those patients who commit offences may actually be kept in psychiatric detention for longer periods than they would actually have spent in prison for the same offence.1

Current legislative frameworks in the UK seem to protect third parties more than they protect the mentally ill patient. It sees the professional role of psychiatrists as having an obligation to protect the public from these people. This conflicts with the altruistic role of psychiatrists and indeed, the profession complains that such attitude is in conflict with the Declaration of Madrid5 which puts values towards patients and altruism as the defining intention of the profession.

These problems therefore frequently put psychiatrists at odds with the principle of nonmaleficence6 and the current western view of the relationship between a doctor and a patient being a contract is at odds with Hippocratic ideals. It also risks making the psychiatric encounter too utilitarian, that is, based on the value of a person balanced against his or her value/risk to society.7 This risk/benefit analysis on patients is perhaps a morally repugnant reflective equilibrium, which justifies the plea of modern psychiatrists. This, apart from the fact that patients may in the long run loose trust in the profession.

Michele Foucault has noted how ‘madness’ was not always seen as a responsibility of the medical profession. Indeed mental patients were often detained with criminals in France. In time they fell under the care of doctors and eventually the field of psychiatry came to be. Moreover treatment in psychiatry was often unorthodox, especially those preceding current Electroconvulsive therapy. Certainly hitting someone in the head with a stick is not normal. Detaining people in cages and boxes seems repulsive today, yet we still occassionally detain people in strait jackets and others locked up in small rooms without proper facilities; and if nursing staff are unavailable patients may not get their daily walk outside. This is more often the responsibility of the state than the institution itself. But the vulnerabilities of mental patients remain. Unfortunately, locally, only patients who suffer from more severe mental illness are entitled to free medication, through the Schedule V (Yellow Card) scheme.

One has to acknowledge that if the field is not to recede back to a state where psychiatric patients are locked away (although not permanently but for longer periods than they should) then society must certainly listen to the psychiatrists themselves, who are the people entrusted by society to look after, in the best possible manner, our mentally ill. They are the professionals who can see what kind of treatment and/or action is justified and what is not, Societies’ feelings should not trump, because of fear, over the limited autonomy of mentally ill patients. For this reason alone it is imperative that the all-important field of biomedical and clinical ethics is not left only to legislators and other professionals who are not medical people and certainly cannot share the same encounter with patients.

References

1. Sarkar S, Adshead G. Protecting altruism: a call for a code of ethics in British Psychiatry, Editorial, The British Journal of Psychiatry 2003; 183:95-7.

by Pierre Mallia MD MPhil PhD MRCP FRCGPAssociate Professor of Family Medicine and Patients’ RightsDepartment of Family Medicine, Medical SchoolUniversity of Malta

The Centre for Bioethics and Patient Advocacy has been taking part in the European Forum for Good Clinical Practice (EFGCP)’s formulation of guidelines for implementing Directive 2001/20/EC relating to good clinical practice in the conduct of clinical trials on human subjects. The document produced by this group focused on clinical trials in children and their protection thereof. As clinical trials become more important and common, a harmonization of the application of this directive across Europe was deemed important.

“Children are not small adults and there is a need to carry out specific trials that cannot be performed in adults.” Ethics committees need paediatric expertise as the lack of competence of children to give informed consent renders this group a vulnerable population. In particular parents are prone to accept their children participating in a trial upon the suggestion of the health care team. The lack of legal ability to consent has therefore also implications on the design, analysis and the choice of comparators used in trials. There is a need for clinical trials in children, especially because many drugs given to them are off-label. Moreover trials may be specific to this population, such as vaccinations.

The Declaration of Helsinki states that, “When a subject deemed legally incompetent, such as a minor child, is able to give assent to decision about participation in research, the investigator must obtain that assent in addition to the consent of the legally authorized representative.” This implies that enough information must be given to the child by an experienced professional, which the child is able to assimilate and understand. Article 4 of the Clinical Trials Directive stipulates therefore “the explicit wish of a minor who is capable of forming an opinion and assessing this information to refuse participation or to be withdrawn from the clinical trial at any time is considered by the investigator or where appropriate the principle investigator.”2

As the child however is only capable of giving assent and not informed consent, one still needs to follow the five conditions4,5 to obtain valid consent from the legal representative of the child. Sufficient time to consider the risks and benefits should be allowed for.2 The document divides children into four age groups. Those under three years of age cannot give realistic assent whilst those over three are thought to understand some form of altruism. As the child gets older, children may be able to understand and evaluate the risks and benefits of the research, and their expression must therefore be taken into account. The fourth group, adolescents, proves most difficult. Sometimes there can be situations in which confidentiality is at stake - some EU states advice discretion and professional secrecy vis-à-vis parents when dealing with this group. Obtaining consent from parents becomes difficult, if legally required, when assent is available form the adolescent, who is technically still considered a child under the legal guardianship of the parents. Conversely, “when the child is legally emancipated, i.e. ceases to be a minor, informed consent must be sought directly from the individual and as soon as possible”.2

The Clinical Trials Directive requires the need for ethics committees to have paediatric expertise to give advice in the clinical, ethical and psychosocial problems in the field of paediatrics, which differ of course from the usual clinical trials in adults. This may be a paediatrician experienced in paediatric research and trials, but also a paediatric pharmacologist, paediatric nurse, paediatric ethicist or psychologist. If the ethics committee is not in charge of scientific review according to national law, it should make sure that adequate peer review by experts in the field has taken place – for example that the trial uses age-appropriate formulations of the medicinal product, or that appropriate amounts of blood are drawn, where this is necessary, considering that the volume of blood to be drawn is over and above that for the normal hospital stay. An amount not more that 1.2 ml has been suggested for children under three, especially babies.

Equipoise is important when considering a control group or the use of a placebo. The physician must be morally certain that the child is not better off not participating in the trial. Equipoise may be waived however when the trial does not involve control groups, for example post-marketing surveillance studies. It has also been suggested that research on certain drugs, following of course the scientific advice given by the professionals mentioned, should be offered only on premises where appropriate “rescue treatment and escape procedures” are available, should a serious harm occur.2

Of course an obvious requirement is that physical and emotional pain should be prevented as much as possible. To do this however requires appropriate monitoring on a regular basis according to guidelines and validated scales, particularly in pre-term, newborn and other children who cannot express themselves. Effective treatment in relation to the intensity of pain should be administered and reviewed regularly. Repeated blood sampling and the insertion of indwelling catheters are all sources of pain, and available pharmacokinetic data from population studies may reduce the number of samples in each child.

Risk assessment is crucial when assessing trials. In children particularly, besides the physical risks, one must consider the psychological or social risks, which may be immediate or delayed and which may vary according to age. Absenteeism from school may be a small issue to the health care team, but may have a large impact over a stretched period of time. It is often the case that the research is spread over the availability of the research team and not of the child’s timetable. Ethics committees may intervene when it is deemed that the particular age group may be adversely affected, and that appropriate arrangements, such as the use of holidays, are used to bring children to the facilities, unless one is dealing with hospitalised children. It is all too easy to instruct parents that they must then continue to bring in the child once a week (when this may not have been adequately expressed in the informed consent process). Parents are usually the first to express concern about how much time is lost from school.

However the risk-benefit analysis may evolve over time, especially where the safety of the drug is concerned, and this must be continuous evaluated, with the provision of being able to stop the study if necessary. There are various protocols and tables of assessing what are minimal risks, and which are major ones. These must be presented by the trial sponsors and need to be evaluated by the Ethics Committee, which usually tries to ascertain that risks are minimal as well as the burden, and that the research has the aim of providing significant improvements in the scientific understanding of the condition or disease, which are able to provide benefit to the participant of the trial and other persons of the same age category.

More tricky are phase one trials, in which healthy volunteers are used. Healthy children must be used in order to understand the pharmacokinetics and pharmacodynamics of a drug, without the interference of the disease process. Phase one involves small numbers, usually in the order of tens; but still, assessing and imparting information of risk may be more difficult, unless one produces prior evidence of adult studies, or at least animal studies. This may not be necessary where the aim is to find age-appropriate dosages or for trials for vaccines. Whenever possible, it is suggested that older children should be considered for inclusion before younger ones, although the document2 does not give particular reasons for this, other than the impression that the younger the child, the more vulnerable they are, and probably the more prone to risks. This may reduce the impact on future tests on younger children.

Finally the directive admonishes researchers performing research in non-EU countries, to strictly follow the same guidelines and GCP standards that are required within the EU. Indeed this is not only about patient rights, but at the end of the day, also about the scientific validity of the trial, for research which is not up to Good Clinical Practice standards has been found not to be scientifically valid.

References

1. European Commission. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, Official Journal L121,01/05/2001:34-44.

2. European Commission. Ethical Considerations for Clinical Trials on Medicinal Products with the Paediatric Population - Recommendations of the ad hoc group for the development of implementing guidelines for Directive 2001/20/EC relating to good clinical practice in the conduct of clinical trials on medicinal products for human use. 2008.

After so much debate over the last couple of years on IVF, one cannot say the final word has been said. We have certainly driven ourselves into a cul de sac, especially when both former Archbishop, and President of the Republic made relevant statements effectively halting the debate. Yet parliament still has an obligation to regulate a technology, which has been introduced into the country. Shying away certainly does no good; neither does deviating arguments to issues on the embryo.

Admittedly, the failure of discussions on IVF have centred mostly around concerns for the embryo. One columnist asserted it was about ‘embryocide’, making allegations that we are not being charitable to the truth. Whilst embryocide is certainly a concern, it is not the main issue in IVF. Embryocide, if it occurs, can be stopped. The main problem is a conflicting issue between a morality of a cherished institution and the ethical decision-making which is the responsibility of our parliamentarians, who unfortunately did not engage in a fruitful discussion on how to legislate, other than a report made by the Parliamentary Committee for Social Affairs.

The main concerns on IVF are that the Roman Catholic Church officially considers this technology as illicit. It is illicit not because of killing of embryos but because the natural conjugal act of the couple is taken away from procreation and it involves the manual stimulation of the male. The second problem which no one seemed to address is the second article in the constitution asserting this Religion as the official religion; is there any constitutional implications towards effective legislation in this area?

Certainly one cannot mince morality with ethical decision-making. The Church’s position is not likely to change in the near future. Yet many within the Church, not least the director of Cana Movement on a radio programme with me on RTK, asserted that if regulated legitimate couples should be able to avail themselves of this technology.

Certainly the use of IVF by couples has to be seen within the light of an existent relationship; no one will go through the expense without commitment to each other. It may not be within the normative values of the country to offer it to anyone else – singles, for example. Yet it is certainly a right of couples to make an ethical decision with regards to IVF, based on counsel obtained even from their pastoral connections, and an obligation on the part of the state to regulate what has been going on for years.

Many see IVF as a good in itself. This cannot be overseen. It has given many couples satisfaction. The government may, due to other pressures or beliefs, not decide to offer this on a national health service. But the fact that it allows private hospitals to make use of this technology shows it acknowledges its value. It cannot therefore shy away from legislating to regulate, and indeed protect the embryo from actions it deems immoral. To this effect, the same document Donum Vitae, which sees IVF as illicit, guides governments to regulate IVF according to sound principles to protect life, where this is existent. Conversely, the Bioethics Consultative Committee, after producing a document on the issue, and bringing the debate to the hands of the parliamentary committee for social affairs has certainly done more than its fair share.

Although it is noble for married couples who turn up to be infertile to accept their condition and not have children, this certainly cannot be imposed on them by society. That couples have a right to try whatever means to have children does not mean that children are being treated as objects owned by parents. It is not incompatible with moral law to treat such children as gifts as any other child. Conversely if it is natural that as we frown upon the breakdown of marriages, we do so as well on any unregulated use of this technology. Whilst liberal countries will not shy away from offering this technology to who is ready to pay for it, we must not allow legitimate couples to suffer because of slippery slope arguments. Certainly IVF is a service being offered, then government has an obligation to regulate or censure; either way the cooperation of the President and ecclesiastical authorities must be ensured to harmonise such decisions and not paralyse people’s representatives in parliament. It would mean defining what constitutes a legitimate couple; but that, then, is a different argument. In an ideal world, or in yester world, marriage was the prime stone of societies’ edifice; today GPs see the unfortunate scores of young people marrying, separating and settling down on longer relationships. Some are infertile. This behoves the question, ‘Do the same patient rights apply to them? Should we offer IVF to them?’. Saying no may mean redefining the Hippocratic Oath, Declaration of Helsinki and what have you.

The aim of having a Centre for Bioethics and Patient Advocacy (or Centre for Bioethics, for short) is to have a centre for academic excellence in bioethics, which is still lacking in Malta. The objectives are met by:

1. Providing scholars and health professionals with a forum for encounter and to sustain literature in the field;

2. To participate in local and international projects and seminars in the field;

3. Study local issues as they arise, including patient and research issues;

4. To provide good clinical practice standards with particular reference to research.

The Centre is an independent entity and although the board is composed mostly of university scholars, it remains independent from this institution. It is not therefore a University initiative, although one must admit that the board is studying whether it should be maintained under the aegis of the University or not. The board remains composed of people who are either experts in the field, or who have relevant experience to contribute.

Scholars, up till now, have participated in the teaching of ethics, where this was approved either formally or informally; they have participated in debate only when requested to do so and through the limited forums of the country. However there are problems with this scenario - local ethics committees, for example, do not have the resources or remit to be a centre of academic excellence. Conversely a lot of debate goes on in the media. This is acceptable and also important. But certainly it is not the forum for scholarly research and where to express, debate and develop opinions.

Scholars, be they students or lecturers, in the field, need to participate in international meetings, especially those relating to their area of research. At the moment for example, the centre is participating with the European Forum for Good Clinical Practice on research in children and on children’s medicines. Funds are necessary to participate in these meetings. The Centre thus uses its resources to be able to advance the professional development and involvement in such areas.

On the other hand there are local issues. These range from issues pertaining to patient rights, such as health insurance, to issues which may pose moral problems in the local context such as the recent attempt to legislate IVF regulation. When evaluating the outcome of this attempt, one should also consider that the lack of support for an academic forum at a tertiary level has contributed negatively to this effect.

Research (on human subjects and on animals) is an area not only of great interest, but of great importance to the advancement of health care. The awareness of ethical standards should not be there to hinder such research, but rather to aid it. Whilst researchers may have a need for clarification of issues such as how to obtain approval from an ethics committee, or how to properly obtain an informed consent, the public may need help in understanding the need for research and what they are gaining or giving up (if anything) in the process. This therefore does not only apply to research on humans, but also to research on animals. There is no legislation or framework to allow research on animals to go on unhindered. It is acceptable having people on committees from animal rights group. However it is not acceptable when these individuals are not acquainted with international guidelines on research on animals – which is in fact not prohibited, but regulated.

These issues are discussed in the courses on Research Ethics which the Centre has been offering. These courses are an end in themselves. Since the Centre is independent, they are not university courses; they are merely intended to provide knowledge in an area that needs dissemination.

What does the future hold? Certainly the first objective is to see whether the centre should remain independent or form part of the University of Malta. There are pros and cons to this. Independency must be maintained in order to respect the main aim and objectives. On the other hand, when it comes to teaching, a certain degree of mutual cooperation with our tertiary institution should be in place, for this to happen.

There is more to bioethics however than abortion, euthanasia or IVF. Bioethics is about bringing people from different areas together in order to reach solutions to individual rights and freedoms. What should primary care in the future hold for the patient? What is the position of patients who are informed by their insurance company that it wishes to have a look into their hospital file after they have made a claim? We can bring concerned parties together in a forum to discuss these issues and reach appropriate agreements. Although insurance companies must look into risk analysis, this must be balanced against the rights and freedoms of the individuals.

The Centre is certainly in its embryonic stage, but the work it has done has already generated interest and concerns. Important courses such as Research Ethics, and Law and Medical Ethics have already been offered and a course on Genetic Counselling and other topics are in preparation.

The Centre already has links to various organisations and is handling a joint conference between the University of Malta and the University of Montpellier on bioethics. Of course there are those who would have reservations, and those who may frown upon such initiatives. But perhaps that is a characteristic of our island nation. Certainly there is an academic void. Certainly as well, our survival naturally depends on the good will of those involved.